Extensive Stage Small Cell Lung Cancer
Conditions
Keywords
ES-SCLC, Tarlatamab, AMG 757, AB248, Imdelltra
Brief summary
The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248. The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.
Interventions
DRUGTarlatamab
Administered as an IV infusion.
DRUGAB248
Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.
Sponsors
Amgen
Asher Biotherapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Participant has provided informed consent before initiation of any study-specific activities/procedures. 2. Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. 3. Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC. 4. Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated. 5. Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver). 6. Participants must submit a fresh tumor biopsy at screening unless a new biopsy cannot be performed safely or is infeasible. Participants who cannot provide fresh tissue may provide archival tissue that was collected after last anticancer therapy.
Exclusion criteria
1. Symptomatic central nervous system (CNS) metastases. 2. Participants with brain metastases may be eligible if criteria defined in the protocol are met. 3. Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab). 4. Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy. 5. Baseline (at rest) requirement of supplemental oxygen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to 2.5 years | Clinically significant changes in vital signs and clinical laboratory tests will be reported as adverse events. |
| Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs) | Up to 35 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Serum Concentration (Cmax) of Tarlatamab | Up to approximately 21 weeks |
| Minimum Serum Concentration (Cmin) of Tarlatamab | Up to approximately 21 weeks |
| Area Under the Concentration-time Curve (AUC) of Tarlatamab | Up to approximately 21 weeks |
| Half-life (t1/2) of Tarlatamab | Up to approximately 21 weeks |
| Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Up to 2.5 years |
| Duration of Response (DOR) per RECIST 1.1 | Up to 2.5 years |
| Time to Response (TTR) per RECIST 1.1 | Up to 2.5 years |
| Disease Control (DC) per RECIST 1.1 | Up to 2.5 years |
| Progression-free Survival (PFS) per RECIST 1.1 | Up to 2.5 years |
| Time to Progression (TTP) per RECIST 1.1 | Up to 2.5 years |
| Time to Subsequent Therapy | Up to 2.5 years |
| Overall Survival (OS) | Up to 2.5 years |
| Number of Participants with Anti-AB248 Antibody Formation | Up to 2.5 years |
Countries
South Korea, Turkey (Türkiye), United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed